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Thursday 12 March 2015
Sir Rory Statin to re-examine trial data after concerns over the heart drug.
Prof Rory Collins, whose research helped rubber stamp statins as safe, said his team will carry out a “challenging” reassessment of the evidence which will include studying all reported side effects.
Although the original research looked at the effect of statins on the heart and considered cancer risks it did not examine other side effects.
Separate studies and patient complaints have included muscle pain, cataracts, diabetes, fatigue and memory loss. Dr Collins, who championed the controversial drug, said the additional work was needed to convince the public that statins were safe.
Fiona Godlee, editor in chief of the British Medical Journal, which has spearheaded calls for access to statins data, said: “This is of real concern. We wrongly assumed all the details of possible side effects had been thoroughly assessed before new guidance effectively made tens of thousands of people eligible for this drug.
We now know this is not the case and would urge any re-analysis is done in the most transparent way.”
Her comments came as Dr Sarah Wollaston, chairwoman of the Commons Health Select Committee, called for drug companies to release all their trial data.
Her demand is echoed by experts at the British Medical Journal, which is writing to the authors of all the major statin trials asking for the release of findings which have not been made available for public or independent analysis.
This follows a massive expansion in statin prescribing under new guidance from the Government’s drug watchdog, the National Institute for Health and Care Excellence.
Klim McPherson, professor of public health at Oxford University, said: “We know these drugs have side effects but we do not know if these have been assessed properly by the drug companies who carried out the trials.
“It is outrageous. Why do they not make their data available for scrutiny?” Prof McPherson, 73, who recently weaned himself off a two-year statin prescription after debilitating muscle pains, added: “Taking these drugs should be a matter of individual patient preference with patients fully aware of their risks, which at the moment is not the case.”
Last year leading doctors’ magazine Pulse revealed two thirds of GPs are disregarding Nice advice to offer statins to more patients.